Fluconazole News

FRIDAY, Nov. 4, 2016 – Federal health officials say 13 cases of a potentially deadly, drug-resistant fungal infection have been reported in the United States. Four of those cases ended in death, but health officials said it's not clear if the deaths were due to the infection or the patients' underlying health conditions. Candida auris fungal infection is emerging as a health threat worldwide, and it appears to spread in hospitals and other health care facilities, according to the U.S. Centers for Disease Control and Prevention. "We need to act now to better understand, contain and stop the spread of this drug-resistant fungus," CDC Director Dr. Tom Frieden said in an agency news release. "This is an emerging threat, and we need to protect vulnerable patients and others." Of the 13 U.S. cases reported between May 2013 and August 2016, seven are described in the CDC's Nov. 4 Morbidity ... Read more

ISSUE: FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete. The current FDA drug label states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections. However, high doses of oral fluconazole (400-800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg. BACKGROUND: Oral fluconazole is used to ... Read more

TUESDAY, April 26, 2016 – Doctors should use caution when prescribing the antifungal drug fluconazole during pregnancy because it may raise the risk of miscarriage, the U.S. Food and Drug Administration warns. Fluconazole (brand name Diflucan) is used to treat vaginal yeast infections. "Patients who are pregnant or actively trying to get pregnant should talk to their health care professionals about alternative treatment options for yeast infections," the FDA advised Tuesday. The agency said it is evaluating the results of a recent Danish study that suggested a link between fluconazole and miscarriage, along with additional data and will release final conclusions and recommendations when the review is completed. Current labeling information suggests that a single 150 milligram (mg) dose of oral fluconazole to treat vaginal yeast infection is safe to take during pregnancy. However, the ... Read more

ISSUE: Sagent has initiated a voluntary recall of one lot of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval. This impurity has been identified as Metronidazole. An elevated impurity has the potential to decrease effectiveness of the product in patients. Patients on the product and on concomitant medication of Metronidazole may receive an increased dose of Metronidazole. BACKGROUND: The lot number being recalled is Lot 40608 which was distributed to hospitals, wholesalers and distributors nationwide from November 2014 through December 2014. Fluconazole Injection, USP, 200mg per 100mL is indicated, for the treatment of Oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is supplied in 100mL and 200mL fle ... Read more

TUESDAY, Jan. 5, 2016 – A well-known antifungal drug used for vaginal yeast infections may be linked to a slightly increased risk of miscarriage, according to a study of more than 1.4 million Danish pregnancies. Of the more than 3,300 women who took oral fluconazole (Diflucan) in the 7th through 22nd week of pregnancy, 147 had a miscarriage, compared with 563 miscarriages among the more than 13,000 women who did not take the drug, the researchers found. "From our study, we can only see that women who have been treated with oral fluconazole more often experience miscarriages than untreated women and women who used a topical [vaginal] antifungal," said lead researcher Ditte Molgaard-Nielsen, an epidemiologist at the Statens Serum Institute in Copenhagen. However, the study cannot prove that fluconazole causes miscarriages, she added. "Our findings cannot precisely show whether ... Read more

-- If you frequent public showers or pools and don't always don your shoes, you may be more prone to nail fungus, a condition medically known as onychomycosis. The Mayo Clinic says common symptoms include nails that are: Unusually thick. Crumbly and brittle. Ragged. Dull with no shine. Abnormally shaped. Unusually dark. Read more

-- Dandruff is an embarrassing problem, but there are home remedies available to help ease flakiness and itching. The Mayo Clinic advises: Keep stress under control, as stress can worsen flaking. Shampoo every day, especially if your scalp is oily. Limit use of styling products, such as hair spray, gel and wax. These can build up and make the scalp oilier. Eat a nutrient-rich diet that includes plenty of zinc and B vitamins. Allow your scalp a bit of safe exposure to sunlight, but take care not to burn. Read more

ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C. BACKGROUND: Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation ... Read more

WEDNESDAY, Aug. 3 – Pregnant women who take ongoing, high doses of the drug fluconazole (brand name Diflucan) may be at increased risk of having babies with birth defects, the U.S. Food and Drug Administration warned Wednesday. The drug is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It's also used to treat meningitis caused by a certain type of fungus and to prevent yeast infections in patients undergoing chemotherapy or radiation therapy prior to a bone marrow transplant. The FDA said chronic, high doses (400 to 800 milligrams per day) of fluconazole during the first trimester of pregnancy may increase the risk of a rare and distinct set of birth defects. There doesn't appear to be any increased risk with a single, low dose (150 mg) to treat vaginal yeast infection. Based on the available information, the FDA has changed the pregnancy ... Read more

THURSDAY, Nov. 18 – Knowing when to take antibiotics – and when not to – can help fight the rise of deadly "superbugs," say experts at the U.S. Centers for Disease Control and Prevention. About half of antibiotics prescribed are unnecessary or inappropriate, the agency says, and overuse has helped create bacteria that don't respond, or respond less effectively, to the drugs used to fight them. "Antibiotics are a shared resource that has become a scarce resource," said Dr. Lauri Hicks, a medical epidemiologist at the CDC. She's also medical director a of new program, Get Smart: Know When Antibiotics Work, that had its launch this week. "Everyone has a role to play in preventing the spread of antibiotic resistance," Hicks said. The stakes are high, said Dr. Arjun Srinivasan, CDC's associate director for health care-associated infection prevention programs. Almost every type of bacteria ... Read more